Pituitary disorders:

Indications for: SOMAVERT

Treatment of acromegaly when response to surgery and/or radiation therapy and/or other medical therapies is inadequate or inappropriate.

Adult Dosage:

Give by SC inj into upper arm, upper thigh, buttocks, or abdomen; rotate inj site. Loading dose: 40mg once (under physician supervision). Maintenance therapy: 10mg daily; may adjust dose in increments/decrements of 5mg every 4–6 weeks based on IGF-I levels. Usual range: 10–30mg daily; max 30mg/day.

Children Dosage:

Not established.

SOMAVERT Warnings/Precautions:

Monitor tumor growth, IGF-I levels, and for the development of GH deficiency. Obtain baseline ALT, AST, TBIL, ALP; if normal, monitor liver function monthly for first 6 months, then quarterly for next 6 months, then biannually for the next year; if elevated but ≤3×ULN, monitor monthly for ≥1yr, then biannually for the next year; if >3×ULN, do not treat until cause of liver dysfunction determined. Liver dysfunction during therapy: if ≥3×ULN but <5×ULN, monitor liver function weekly; if ≥5×ULN, or transaminase elevations ≥3×ULN associated with increase in TBIL, discontinue immediately, consider reinitiation if liver function normalizes with frequent monitoring; if liver injury occurs, discontinue therapy. Diabetes (monitor and adjust doses). Monitor closely when re-initiating therapy after systemic hypersensitivity reactions. Elderly. Pregnancy. Nursing mothers.

SOMAVERT Classification:

Growth hormone (GH) receptor antagonist.

SOMAVERT Interactions:

May need to reduce dose of insulin, oral hypoglycemics. Antagonized by opioids (higher pegvisomant doses may be needed). May cause falsely elevated GH assays.

Adverse Reactions:

Infection, pain, diarrhea, nausea, elevated LFTs, flu syndrome, inj site reaction; lipohypertrophy, systemic hypersensitivity (eg, anaphylaxis, laryngospasm, angioedema, skin reactions).

Drug Elimination:

Half-life: 60–138 hours.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1 (w. diluent)